MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number 11013-29

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the iliac artery.A 10x29 omnilink elite 35 stent delivery system (sds) was used with an unspecified 6f sheath when it became stuck.A same sized omnilink elite 35 sds was used with an unspecified 7f sheath to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual, dimensional and functional analysis was performed on the returned device.The difficulty to remove was confirmed.The difficulty to advance could not be confirmed due to the condition of the device.The review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents.The investigation was unable to determine the cause for the reported difficultly to advance, and difficultly to remove.The difficulty to remove was confirmed.The difficulty to advance could not be confirmed due to the condition of the device.In this case, it may be possible that during prep, the stent was damaged which increased due to the interference with the introducer sheath leading to difficulty advancing and difficulty to remove.The additional deformation and material twisted are related to the circumstances of the procedure.The material separation and stent dislodgement are related to packaging of the product for return.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11170958
• MDR Text Key: 226830073
• Report Number: 2024168-2021-00448
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 11013-29
• Device Lot Number: 9030541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F SHEATH.; 6F SHEATH